Perioperative Systemic Therapies in Muscle-Invasive Bladder Cancer (GUARDIANS)

NCT07855926 | Recruiting

• 1 other identifier: GUARDIANS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, non-interventional, prospective and retrospective observational patient registry study of adults with muscle-invasive bladder cancer receiving perioperative systemic therapy as part of routine clinical care. The registry includes patients treated with perioperative systemic therapies such as Enfortumab Vedotin plus Pembrolizumab as well as cisplatin-based combinations including Gemcitabine/Cisplatin/Durvalumab and other standard perioperative treatment approaches in the neoadjuvant and adjuvant setting. The study aims to evaluate real-world feasibility, treatment tolerability, pathologic response, and oncologic outcomes of perioperative systemic treatment strategies. Key outcomes include event-free survival (EFS), pathologic complete response (pCR), pathologic downstaging, disease-free survival (DFS), overall survival (OS), perioperative complications, and treatment-related adverse events. Patient-reported neurotoxicity symptoms will also be assessed using standardized neuropathy questionnaires. All treatments, surgeries, and follow-up procedures are performed according to routine clinical practice. No study-specific interventions are assigned. Clinical data are collected pseudonymized through participating GUARDIANS centers using standardized electronic case report forms. Both prospective and retrospective data collection are included.

Conditions

Urothelial Carcinoma of the Bladder; Muscle Invasive Bladder Cancer (MIBC)

Keywords

Perioperative Systemic Therapy; Muscle-Invasive Bladder Cancer; Urothelial Carcinoma; Enfortumab Vedotin; Pembrolizumab; Gemcitabine; Cisplatin; Durvalumab; Radical Cystectomy; Neoadjuvant Therapy; Adjuvant Therapy; Real-World Data; Patient Registry; GUARDIANS; CIPN; Pathologic Complete Response; Event-Free Survival

Outcome Measures

Primary Outcomes (1)

• Event Free Survival (EFS)

  From treatment initiation up to 36 months

Secondary Outcomes (8)

• Pathologic Complete Response (pCR)

  At radical cystectomy

• Pathologic Downstaging

  At radical cystectomy

• Disease-Free Survival (DFS)

  Up to 36 months after surgery

• Overall Survival (OS)

  Up to 60 months

• Change Over Time in Patient-Reported Peripheral Neuropathy Assessed by the EORTC QLQ-CIPN20

  Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and end of treatment ±14 days

Interventions

Perioperative Systemic Therapy Registry OTHER

Observational registry of patients with muscle-invasive bladder cancer receiving perioperative systemic therapy as part of routine clinical care. Treatments are not assigned by protocol and may include Enfortumab Vedotin plus Pembrolizumab, Gemcitabine/Cisplatin/Durvalumab, cisplatin-based chemotherapy, immunotherapy, and other standard neoadjuvant or adjuvant treatment approaches. All therapeutic decisions are made independently by treating physicians according to local standard of care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with muscle-invasive or locally advanced urothelial carcinoma of the bladder receiving perioperative systemic therapy in routine clinical practice. Patients are treated in the neoadjuvant and/or adjuvant setting with curative intent and undergo or are planned for radical cystectomy with pelvic lymph node dissection. Treatment approaches include Enfortumab Vedotin plus Pembrolizumab, Gemcitabine/Cisplatin/Durvalumab, cisplatin-based chemotherapy, immunotherapy, and other standard perioperative systemic therapies. Both prospective and retrospective patients from participating GUARDIANS centers are included.

You may qualify if:

• Age ≥18 years
• Histologically confirmed muscle-invasive or locally advanced urothelial carcinoma of the bladder
• Planned, ongoing, or completed perioperative systemic therapy, including but not limited to Enfortumab Vedotin plus Pembrolizumab, Gemcitabine/Cisplatin/Durvalumab, cisplatin-based chemotherapy, immunotherapy, or other standard perioperative treatment approaches
• Radical cystectomy planned or performed as part of curative-intent treatment strategy
• Written informed consent for prospective data collection, where required

You may not qualify if:

• Missing informed consent where prospectively required
• Insufficient documentation of key baseline data or treatment exposure
• No perioperative systemic therapy or inability to assign patient to a study cohort
• Follow-up data unavailable or inconsistent documentation preventing endpoint assessment

Sponsors & Collaborators

• LMU Klinikum: lead

Study Sites (1)

Department of Urology, LMU University Hospital Munich

Munich, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: October 2, 2026
• Study Start: May 17, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2029
• Last Updated: October 2, 2026

Record last verified: 2026-05

Locations

DE (1)